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Compliance & Quality Assurance
ProPharma Group realizes that the identification of Quality Assurance (QA) and Compliance problems is only part of the Compliance Puzzle; knowing what to do about them to mitigate your compliance risk is the key! As a provider of turn-key solutions, ProPharma Group offers the following value-added QA and Compliance services:
Quality Assurance
Our QA staff has extensive experience in regulated environments and brings this value to the table when assisting our clients’ with their QA-related needs.
QA/QC Staff Augmentation
- Policy, SOP and Batch Record Review, Preparation and Optimization
- Quality System (QS) Development, Assessment and Optimization
- QS Auditing / Benchmarking
- Corrective and Preventive Action (CAPA) Planning and Execution
- Training – FDA, GMP, QSR, Validation, Operator, Safety, etc.
Compliance
Our Compliance staff augments our clients’ internal capabilities to prepare for, execute and address compliance-related observations and deficiencies, thus mitigating our client’s regulatory risk.
- Third-party GMP and GLP Compliance Auditing
- Mock FDA/International Regulatory Agency Inspections and PAI Auditing
- Due Diligence Compliance Inspections, Audits and Assistance
- FDA Action (483 Observations, Warning Letters, Consent Decrees) Remediation
Standards and Regulations
ProPharma Group’s senior staff of quality, compliance and program/project management professionals takes a proven, hands-on approach to addressing our clients’ specific QA and Compliance situations to assure that their quality and regulatory operations are in compliance with current industry standards and FDA/international regulations, such as:
Food and Drug Administration (FDA)
- Current Good Manufacturing Practice (GMP) Regulation for Finished Pharmaceutical Products - 21 CFR Part 210/211
- Quality System Regulation (QSR) for Finished Devices - 21 CFR Part 820
- Current Good Manufacturing Practice (GMP) Regulation for Blood and Blood Components - 21 CFR Part 606
- Electronic Records; Electronic Signatures - 21 CFR Part 11
- Guidance For Industry: Manufacturing, Processing or Holding APIs
- Good Laboratory Practice (GLP) Regulation – 21 CFR Part 58
- Guide to Inspections: Validation of Cleaning Processe
International Regulatory Agencies
International Conference on Harmonization (ICH)
- Validation of Analytical Procedures – ICH Q2
- GMP Guide for Active Pharmaceutical Ingredients - ICH Q7
- Pharmaceutical Development - ICH Q8
- Quality Risk Management- ICH Q9
- Pharmaceutical Quality System - ICH Q10
International Organization for Standardization (ISO)
- Quality Management Systems -- Fundamentals and Vocabulary – ISO 9000
- Quality Management Systems – Requirements – ISO 9001
- Medical Devices -- Quality Management Systems -- Requirements for Regulatory Purposes - ISO 13485
Pharmacopeias
- United States Pharmacopeia (USP)
- European Pharmacopeia (EP or Ph. Eur.)
- Japanese Pharmacopeia (JP)
Industry Standards
- Good Automated Manufacturing Practice (GAMP 5)
- Validation Standard ASTM E2500
- Client-specific Internal Policies and Procedures
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